Presbia (NSDQ:LENS) touted interim data today from its U.S. pivotal clinical trial, which it hopes will eventually support pre-market approval from the FDA for its Flexivue Microlens. The company is 2 years into the 3-year long trial and said that it anticipates submitting final data to the FDA in September 2017.
The company’s lens is intended to correct presbyopia, farsightedness that is often age-related. Presbia’s custom lenses are implanted in the patient’s non-dominant eye in the hopes of helping the patient see near objects more clearly. To place the microlens in a patient’s eye, a small pocket is created in the cornea using a femtosecond laser and following the implantation, the pocket seals naturally and the lens sits at the center of the visual axis.
The Flexivue lens was developed to take advantage of binocular vision – when patients use both eyes and the images are fused in the brain, according to Presbia.
Through November 30 of this year, the trial has enrolled 421 participants. All of the study subjects have passed through the 12 month post-operative visit. Presbia said that participants gained, on average, 5 lines of uncorrected near visual acuity in treated eyes. More than 80% of patients achieved at least 20/40 uncorrected distance vision and 98% of participants achieved 20/40 best corrected distance vision in the treated eyes, according to regulatory filings.
LENS shares were trading at $3.69 in mid-morning activity, up 5.1%.